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Novartis kicks off BTK competition in immunology with FDA approval for Rhapsido in chronic hivesNovartis has scored the FDA’s approval for a second BTK inhibitor that’s for a non-cancer indication, teeing off a potential competition with Sanofi down the line. The FDA hasblessedNovartis’ remibru2025/10/17
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Merck unveils data from 2nd Winrevair PAH study previously halted for efficacyTwo clinical trials of Merck’s pulmonary arterial hypertension (PAH) drug Winrevair were so conclusive that the studies were halted within the last year because the efficacy of the treatment was assu2025/10/17
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AZ, Daiichi's Enhertu shows early breast cancer prowess with another trial win, topping Roche's KadcylaAstraZeneca and Daiichi Sankyo’s star antibody-drug conjugate (ADC) Enhertu has chalked up another win in an early breast cancer setting, this time besting Roche’s Kadcyla in a phase 3 study. Enhertu2025/10/14
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GSK's Emma Walmsley to step down as CEO in shock move, giving way to commercial lead Luke MielsThe first woman to helm a Big Pharma will be stepping down in January as GSK’s Emma Walmsley moves aside for her chief commercial officer Luke Miels. Walmsley, 56, who became the British pharma’s CEO2025/10/14
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Sanofi expands $35-per-month pricing to all insulin productsIn an expansion of its previous moves to cut insulin prices, Sanofi willcap the priceof each of its insulin products at $35 per month in the U.S. regardless of a patient's insurance status. The move,2025/10/9
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Asian generics powerhouse Lotus expands US presence with acquisition of AlvogenSerial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterp2025/10/9
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FDA takes close look at mifepristone REMS program after request from Republican AGsIt was only about a year ago that the biopharma industryhaileda decision by the Supreme Court to preserve access to mifepristone, a drug most commonly known for its paired use with another medicine t2025/9/30
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Acadia grounds Prader-Willi candidate after trial failure, leaving the market to SolenoSoleno Therapeutics is breathing easier with a report from Acadia Pharmaceuticals that its candidate to treat hyperphagia in patients with Prader-Willi Syndrome (PWS) hascome up shortin a phase 3 tri2025/9/30
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FDA hands warning letter to J&J subsidiary over stopper issues, spotty reporting at Korean plantA Johnson & Johnson innovate medicine subsidiary, Janssen Vaccines, landed in hot water with the FDA this summer over a 2024 inspection of the company’s production facility in South Korea. In a w2025/9/25
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Biogen plots resubmission after FDA turns down high-dose Spinraza in SMA, requests more production infoDespite possessing a solid data package on the potential of high-dose Sprinraza in spinal muscular atrophy (SMA), Biogen will now need to revise its application if it hopes to secure an FDA nod. The2025/9/25